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Peer-reviewedCC BY-NC-NDNature communications

Ociperlimab and tislelizumab in advanced esophageal squamous cell carcinoma (AdvanTIG-203): a phase II study.

  • Feng Wang1
  • Chen-Yuan Lin2,3
  • Jong-Mu Sun4
  • Chang-Hsien Lu5
  • Xueqiang Zhu6
  • Zhendong Chen7
  • Qi Zhao1
  • In-Ho Kim8
  • Yueyin Pan9
  • Jingdong Zhang10
  • Zhaohong Chen11
  • David Tougeron12
10 more authors
  • Sung-Bae Kim13
  • Eric Van Cutsem14
  • Aziz Zaanan15
  • Fernando Rivera16
  • Arunee Dechaphunkul17
  • Yunxia Zuo18
  • Qiting Wan18
  • Juan Zhang18
  • Jiadong Zhou18
  • Rui-Hua Xu19
19 affiliations
  1. 1Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, China.
  2. 2China Medical University Hospital, Taichung, Taiwan, ROC.
  3. 3School of Pharmacy, China Medical University, Taichung, Taiwan, ROC.
  4. 4Samsung Medical Center, Seoul, South Korea.
  5. 5Chiayi Chang Gung Memorial Hospital, Puzi City, Taiwan, ROC.
  6. 6Sichuan Provincial People's Hospital, Chengdu, China.
  7. 7The Second Hospital of Anhui Medical University, Hefei, China.
  8. 8The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, South Korea.
  9. 9Anhui Provincial Hospital, Hefei, China.
  10. 10Liaoning Cancer Hospital & Institute, Shenyang, China.
  11. 11People's Hospital of Deyang City, Deyang, China.
  12. 12CHU de Poitiers, Poitiers, France.
  13. 13Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
  14. 14University Hospitals Gasthuisberg/Leuven and University of Leuven, Leuven, Belgium.
  15. 15Department of Gastroenterology and Digestive Oncology, Hôpital Européen Georges Pompidou, Paris-Cité University, Paris, France.
  16. 16Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
  17. 17Medical Oncology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.
  18. 18BeOne Medicines, Ltd, Shanghai, China.
  19. 19Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, China. [email protected].
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Abstract

Patients with esophageal squamous cell carcinoma (ESCC) have an unmet need for new therapies that improve survival. In this phase II trial, patients received ociperlimab and tislelizumab (A) or placebo and tislelizumab (B) (NCT04732494). The primary endpoint was objective response rate (ORR) assessed by the investigator per RECIST v1.1. A total of 125 patients were randomized to A (N = 62) and B (N = 63). The primary endpoint was not met, with an ORR (95% confidence interval [CI]) assessed by the investigator of 30.6% (19.6-43.7) for A and 20.6% (11.5-32.7) for B (stratified risk difference: 9.9% [95% CI - 5.4 to 25.3]; stratified 2-sided p = 0.2114). At the final analysis, median OS (95% CI) was 10.2 (7.9-19.5) months for A and 9.3 (6.4-14.8) months for B (stratified HR [95% CI]: 0.92 [0.58-1.45]). A total of 25.8% (16/62) and 20.6% (13/63) of patients in A and B, respectively, experienced grade ≥3 treatment-related treatment-emergent adverse events. Exploratory biomarker analyses showed that patients with an inflamed tumor microenvironment, shown by the enriched expression of natural killer (NK) cells, T cells, macrophages, dendritic cells, and B-cell signatures, and NK cell signature enrichment, may benefit from ociperlimab plus tislelizumab. Adding ociperlimab to tislelizumab did not provide significant efficacy improvement in recurrent/metastatic second-line ESCC; the addition of ociperlimab to tislelizumab was generally well-tolerated. Trial registration: Clinicaltrials.gov: NCT04732494.

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Cite

BibTeXRIS
BibTeX
@article{wang2026ociperlimab,
  title = {{Ociperlimab and tislelizumab in advanced esophageal squamous cell carcinoma (AdvanTIG-203): a phase II study.}},
  author = {Feng Wang and Chen-Yuan Lin and Jong-Mu Sun and Chang-Hsien Lu and Xueqiang Zhu and Zhendong Chen and Qi Zhao and In-Ho Kim and Yueyin Pan and Jingdong Zhang and Zhaohong Chen and David Tougeron and Sung-Bae Kim and Eric Van Cutsem and Aziz Zaanan and Fernando Rivera and Arunee Dechaphunkul and Yunxia Zuo and Qiting Wan and Juan Zhang and Jiadong Zhou and Rui-Hua Xu},
  journal = {Nature communications},
  year = {2026},
  month = sep,
  doi = {10.1038/s41467-026-77705-8},
  url = {https://europepmc.org/article/MED/42901884},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Ociperlimab and tislelizumab in advanced esophageal squamous cell carcinoma (AdvanTIG-203): a phase II study.
AU  - Feng Wang
AU  - Chen-Yuan Lin
AU  - Jong-Mu Sun
AU  - Chang-Hsien Lu
AU  - Xueqiang Zhu
AU  - Zhendong Chen
AU  - Qi Zhao
AU  - In-Ho Kim
AU  - Yueyin Pan
AU  - Jingdong Zhang
AU  - Zhaohong Chen
AU  - David Tougeron
AU  - Sung-Bae Kim
AU  - Eric Van Cutsem
AU  - Aziz Zaanan
AU  - Fernando Rivera
AU  - Arunee Dechaphunkul
AU  - Yunxia Zuo
AU  - Qiting Wan
AU  - Juan Zhang
AU  - Jiadong Zhou
AU  - Rui-Hua Xu
PY  - 2026
DA  - 2026/09/18
JO  - Nature communications
DO  - 10.1038/s41467-026-77705-8
UR  - https://europepmc.org/article/MED/42901884
AB  - Patients with esophageal squamous cell carcinoma (ESCC) have an unmet need for new therapies that improve survival. In this phase II trial, patients received ociperlimab and tislelizumab (A) or placebo and tislelizumab (B) (NCT04732494). The primary endpoint was objective response rate (ORR) assessed by the investigator per RECIST v1.1. A total of 125 patients were randomized to A (N = 62) and B (N = 63). The primary endpoint was not met, with an ORR (95% confidence interval [CI]) assessed by the investigator of 30.6% (19.6-43.7) for A and 20.6% (11.5-32.7) for B (stratified risk difference: 9.9% [95% CI - 5.4 to 25.3]; stratified 2-sided p = 0.2114). At the final analysis, median OS (95% CI) was 10.2 (7.9-19.5) months for A and 9.3 (6.4-14.8) months for B (stratified HR [95% CI]: 0.92 [0.58-1.45]). A total of 25.8% (16/62) and 20.6% (13/63) of patients in A and B, respectively, experienced grade ≥3 treatment-related treatment-emergent adverse events. Exploratory biomarker analyses showed that patients with an inflamed tumor microenvironment, shown by the enriched expression of natural killer (NK) cells, T cells, macrophages, dendritic cells, and B-cell signatures, and NK cell signature enrichment, may benefit from ociperlimab plus tislelizumab. Adding ociperlimab to tislelizumab did not provide significant efficacy improvement in recurrent/metastatic second-line ESCC; the addition of ociperlimab to tislelizumab was generally well-tolerated. Trial registration: Clinicaltrials.gov: NCT04732494.
SN  - 2041-1723
ER  -